AQUACEL® Ag Dressing and Urgotul® Silver Dressing on Healing of Chronic Venous Leg Ulcers

Phase 4

Completed

• Conditions: Leg Ulcer

• Registration Number: NCT01084577
• Lead Sponsor: ConvaTec Inc.

Brief Summary

A prospective, comparative, randomised study to compare the effects on ulcer healing of AQUACEL® Ag dressing when used for 4 weeks followed by treatment with AQUACEL® for 4 weeks to Urgotul® Silver dressing followed by Urgotul® for 4 weeks on subjects with venous leg ulcers.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2010-03-09
• Study First Posted: 2010-03-10
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-17
• Last Update Posted: 2011-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

• Subjects over 18 years, willing and able to provide written informed consent.
• Subjects who have an ankle to brachial pressure index (ABPI) of 0.8 or greater.
• Subjects who have a venous leg ulcer (i.e. CEAP classification of C6), with duration less than 24 months and size ranging between 5 cm2-40 cm2 .
• Subjects' leg ulcers will meet at least 3 of the 5 following clinical signs: pain between 2 dressing changes, perilesional skin erythema, oedema, foul odour, and heavy exudation.
• Subjects agree to wear compression therapy daily in combination with the trial dressing.

Exclusion Criteria

• Subjects with a history of skin sensitivity to any of the components of the study product.
• Subjects who have had current local or systemic antibiotics in the week prior to inclusion.
• Subjects whose leg ulcers are clinically infected or erysipelas, malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months.
• Subjects who have a progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents or high dose corticosteroids.
• Subjects who have participated in a clinical study within the past 3 months.
• Subjects who are pregnant or breastfeeding (in accordance with the Urgotul® Silver package insert).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Wound area reduction from baseline (relative)	8 weeks

Secondary Outcome Measures

Name	Time	Method
Wound closure	8 weeks
Clinical evolution of the wound	8 weeks	presence of each of the 5 selected clinical signs
Tolerance	8 weeks	occurrence of local adverse events

Trial Locations

Locations (56)

Arhus Universitets Hospital (#47); 🇩🇰 Arhus, Denmark

Bispebjerg Universitets Hospital (#45); 🇩🇰 Copenhagen, Denmark

Odense Universitets Hospital (#46); 🇩🇰 Odense, Denmark

(#35); 🇫🇷 Paris, Neuilly sur Siene, France

37 Bd Bury (#42); 🇫🇷 Angouleme, France

CH de La Fere, (#44); 🇫🇷 La Fere, France

Clinique des Augustines (#38); 🇫🇷 Malestroit, France

19 rue des Clers (#37); 🇫🇷 Metz, France

Hopital Brocca, 54/56 rue Pascal (#41); 🇫🇷 Paris, France

Centre de Sante (#36); 🇫🇷 Paris, France

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